Estrogen receptor and androgen receptor imaging in metastatic breast cancer patients

Phase 1

• Conditions: Estrogen receptor positive metastatic breast cancer patients; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-003981-42-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-22
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Metastatic breast cancer, with at least one known metastasis outside of the liver
2. Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
3. Postmenopausal status defined as one of the following:
a. age =60 years
b. previous bilateral oophorectomy
c. age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
d. patients age <60 years using an ER-antagonist should have amenorrhea for > 12 months and FSH >24 U/L and LH >14 U/L
e. patient age <60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures
4. Initially ER-positive tumor histology.
5. ECOG performance status 0-2.
6. Signed written informed consent
7. Able to comply with the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study
2. Life-expectancy = 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified